Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes
Background Prompt and reliable management of hypoglycemia in youth with diabetes is important to prevent serious medical complications. Objectives To determine efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of a ready‐to‐use, liquid stable glucagon formulation admin...
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| Veröffentlicht in: | Pediatric diabetes 2022-09, Vol.23 (6), p.754-762 |
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| container_title | Pediatric diabetes |
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| creator | Buckingham, Bruce Sherr, Jennifer Prestrelski, Steven J. Conoscenti, Valentina |
| description | Background
Prompt and reliable management of hypoglycemia in youth with diabetes is important to prevent serious medical complications.
Objectives
To determine efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of a ready‐to‐use, liquid stable glucagon formulation administered subcutaneously via an autoinjector pen to youth with type 1 diabetes (T1D).
Methods
After plasma glucose concentration was |
| doi_str_mv | 10.1111/pedi.13360 |
| format | Article |
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Prompt and reliable management of hypoglycemia in youth with diabetes is important to prevent serious medical complications.
Objectives
To determine efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of a ready‐to‐use, liquid stable glucagon formulation administered subcutaneously via an autoinjector pen to youth with type 1 diabetes (T1D).
Methods
After plasma glucose concentration was < 80 mg/dL (< 4.4 mmol/L) after insulin, participants aged 2 to < 12 years with T1D were administered 0.5 mg of glucagon; participants aged 12 to < 18 years instead received 1 mg of glucagon. Then, adolescents were challenged with 0.5 mg after a 7‐ to 28‐day washout period. Primary endpoint was mean plasma glucose concentration at 30 min after glucagon.
Results
Plasma glucose concentrations significantly (p < 0.001) increased from baseline to 30 min after glucagon, with mean change in plasma glucose concentration between baseline and 30 min for each age cohort as follows: 2 to < 6 years (n = 7; 81.4 mg/dL [4.5 mmol/L]); 6 to < 12 years (13; 84.2 mg/dL [4.7 mmol/L]); 12 to < 18 years (11; dose, 1 mg; 54.0 mg/dL [3.0 mmol/L]); and 12 to < 18 years (11; 0.5 mg; 52.4 mg/dL [2.9 mmol/L]). Among age cohorts, no clinically relevant differences were observed for PD and PK parameters. Common adverse events were nausea, vomiting, and hypoglycemia.
Conclusion
Age‐appropriate dosing of this glucagon formulation was effective at 30 min in reversing plasma glucose concentrations from < 80 mg/dL in youth with T1D.]]></description><identifier>ISSN: 1399-543X</identifier><identifier>EISSN: 1399-5448</identifier><identifier>DOI: 10.1111/pedi.13360</identifier><identifier>PMID: 35562186</identifier><language>eng</language><publisher>Former Munksgaard: John Wiley & Sons A/S</publisher><subject>Age ; Diabetes ; Diabetes mellitus (insulin dependent) ; Dosage ; Glucagon ; Glucose ; Hypoglycemia ; Insulin ; Nausea ; pediatric ; Pharmacodynamics ; Pharmacokinetics ; Plasma ; Vomiting</subject><ispartof>Pediatric diabetes, 2022-09, Vol.23 (6), p.754-762</ispartof><rights>2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><rights>2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2460-a13d03774b69e7cdca40546fb538493ce62ceab138e3060c40a4de88346d427e3</cites><orcidid>0000-0003-4581-4887 ; 0000-0001-9301-3043</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fpedi.13360$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fpedi.13360$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35562186$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Buckingham, Bruce</creatorcontrib><creatorcontrib>Sherr, Jennifer</creatorcontrib><creatorcontrib>Prestrelski, Steven J.</creatorcontrib><creatorcontrib>Conoscenti, Valentina</creatorcontrib><title>Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes</title><title>Pediatric diabetes</title><addtitle>Pediatr Diabetes</addtitle><description><![CDATA[Background
Prompt and reliable management of hypoglycemia in youth with diabetes is important to prevent serious medical complications.
Objectives
To determine efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of a ready‐to‐use, liquid stable glucagon formulation administered subcutaneously via an autoinjector pen to youth with type 1 diabetes (T1D).
Methods
After plasma glucose concentration was < 80 mg/dL (< 4.4 mmol/L) after insulin, participants aged 2 to < 12 years with T1D were administered 0.5 mg of glucagon; participants aged 12 to < 18 years instead received 1 mg of glucagon. Then, adolescents were challenged with 0.5 mg after a 7‐ to 28‐day washout period. Primary endpoint was mean plasma glucose concentration at 30 min after glucagon.
Results
Plasma glucose concentrations significantly (p < 0.001) increased from baseline to 30 min after glucagon, with mean change in plasma glucose concentration between baseline and 30 min for each age cohort as follows: 2 to < 6 years (n = 7; 81.4 mg/dL [4.5 mmol/L]); 6 to < 12 years (13; 84.2 mg/dL [4.7 mmol/L]); 12 to < 18 years (11; dose, 1 mg; 54.0 mg/dL [3.0 mmol/L]); and 12 to < 18 years (11; 0.5 mg; 52.4 mg/dL [2.9 mmol/L]). Among age cohorts, no clinically relevant differences were observed for PD and PK parameters. Common adverse events were nausea, vomiting, and hypoglycemia.
Conclusion
Age‐appropriate dosing of this glucagon formulation was effective at 30 min in reversing plasma glucose concentrations from < 80 mg/dL in youth with T1D.]]></description><subject>Age</subject><subject>Diabetes</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Dosage</subject><subject>Glucagon</subject><subject>Glucose</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Nausea</subject><subject>pediatric</subject><subject>Pharmacodynamics</subject><subject>Pharmacokinetics</subject><subject>Plasma</subject><subject>Vomiting</subject><issn>1399-543X</issn><issn>1399-5448</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kU1u1TAURiMEoqUwYQHIEhOE3it27DjJEJXSVqrUDkBiFt3YN60fiZ36hyozlsCO2Asrwe17dNABHlxbn47OtfQVxWtGD1k-H2bU5pBxLumTYp_xtl1XQjRPH978217xIoQNpaxuuXhe7PGqkiVr5H7x-_Ia_ATK6cXCZFRYkXmXfDcW430SYMC4rAhYTaIb0UNvRhMX4gYCxCPo5c_PX9HlkQKuiHduIhGnOZMx-ZyM5iYZTUKEfkRyNSYFV84S0JOxJkT0qMkPA3kDgRSdsRtU0Xkyo80byeJSvCa3Jo-4zEgY0QZ6jBheFs8GGAO-2t0HxdfPx1-OTtfnFydnRx_P16oUkq6BcU15XYtetlgrrUDQSsihr3gjWq5QlgqhZ7xBTiVVgoLQ2DRcSC3KGvlB8W7rnb27SRhiN5mgcBzBokuhK6UUddtmaUbfPkI3Lnmbf5eptq2aTDWZer-llHcheBy62ZsJ_NIx2t3V2t3V2t3XmuE3O2XqJ9QP6L8eM8C2wK0ZcfmPqrs8_nS2lf4F3EWyvw</recordid><startdate>202209</startdate><enddate>202209</enddate><creator>Buckingham, Bruce</creator><creator>Sherr, Jennifer</creator><creator>Prestrelski, Steven J.</creator><creator>Conoscenti, Valentina</creator><general>John Wiley & Sons A/S</general><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4581-4887</orcidid><orcidid>https://orcid.org/0000-0001-9301-3043</orcidid></search><sort><creationdate>202209</creationdate><title>Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes</title><author>Buckingham, Bruce ; Sherr, Jennifer ; Prestrelski, Steven J. ; Conoscenti, Valentina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2460-a13d03774b69e7cdca40546fb538493ce62ceab138e3060c40a4de88346d427e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Age</topic><topic>Diabetes</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>Dosage</topic><topic>Glucagon</topic><topic>Glucose</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Nausea</topic><topic>pediatric</topic><topic>Pharmacodynamics</topic><topic>Pharmacokinetics</topic><topic>Plasma</topic><topic>Vomiting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Buckingham, Bruce</creatorcontrib><creatorcontrib>Sherr, Jennifer</creatorcontrib><creatorcontrib>Prestrelski, Steven J.</creatorcontrib><creatorcontrib>Conoscenti, Valentina</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Pediatric diabetes</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Buckingham, Bruce</au><au>Sherr, Jennifer</au><au>Prestrelski, Steven J.</au><au>Conoscenti, Valentina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes</atitle><jtitle>Pediatric diabetes</jtitle><addtitle>Pediatr Diabetes</addtitle><date>2022-09</date><risdate>2022</risdate><volume>23</volume><issue>6</issue><spage>754</spage><epage>762</epage><pages>754-762</pages><issn>1399-543X</issn><eissn>1399-5448</eissn><abstract><![CDATA[Background
Prompt and reliable management of hypoglycemia in youth with diabetes is important to prevent serious medical complications.
Objectives
To determine efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of a ready‐to‐use, liquid stable glucagon formulation administered subcutaneously via an autoinjector pen to youth with type 1 diabetes (T1D).
Methods
After plasma glucose concentration was < 80 mg/dL (< 4.4 mmol/L) after insulin, participants aged 2 to < 12 years with T1D were administered 0.5 mg of glucagon; participants aged 12 to < 18 years instead received 1 mg of glucagon. Then, adolescents were challenged with 0.5 mg after a 7‐ to 28‐day washout period. Primary endpoint was mean plasma glucose concentration at 30 min after glucagon.
Results
Plasma glucose concentrations significantly (p < 0.001) increased from baseline to 30 min after glucagon, with mean change in plasma glucose concentration between baseline and 30 min for each age cohort as follows: 2 to < 6 years (n = 7; 81.4 mg/dL [4.5 mmol/L]); 6 to < 12 years (13; 84.2 mg/dL [4.7 mmol/L]); 12 to < 18 years (11; dose, 1 mg; 54.0 mg/dL [3.0 mmol/L]); and 12 to < 18 years (11; 0.5 mg; 52.4 mg/dL [2.9 mmol/L]). Among age cohorts, no clinically relevant differences were observed for PD and PK parameters. Common adverse events were nausea, vomiting, and hypoglycemia.
Conclusion
Age‐appropriate dosing of this glucagon formulation was effective at 30 min in reversing plasma glucose concentrations from < 80 mg/dL in youth with T1D.]]></abstract><cop>Former Munksgaard</cop><pub>John Wiley & Sons A/S</pub><pmid>35562186</pmid><doi>10.1111/pedi.13360</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-4581-4887</orcidid><orcidid>https://orcid.org/0000-0001-9301-3043</orcidid></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Age Diabetes Diabetes mellitus (insulin dependent) Dosage Glucagon Glucose Hypoglycemia Insulin Nausea pediatric Pharmacodynamics Pharmacokinetics Plasma Vomiting |
| title | Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes |
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